A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Randomised, Multi-Centre, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117455
• Other study ID #: 20020113
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: May 15, 2008

Study information

• Verified date: May 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyItaly: Ministry of HealthSpain: Spanish Agency of MedicinesNorway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Subjects with non-Hodgkin's lymphoma (NHL) who are considered to be suitable candidates for autologous PBPC transplantation per institution guidelines - ECOG 0-2 inclusive - ANC greater than 1.5 x 10^9/L; PLT greater than 100 x 10^9/L Exclusion Criteria: - More than one line (regimen) of previous chemotherapy treatment and more than 2 cycles of any premobilisation salvage chemotherapy prior to enrolment. Patients were also to be excluded from the study if they had received any salvage chemotherapy containing the following agents: procarbazine, nitrogen mustard, nitrosoureas (including BCNU), melphalan and fludarabine. - Previous bone marrow or PBPC transplant - Greater than 20% bone marrow involvement of the disease at time of screening, as demonstrated by biopsy

• Prior total nodal irradiation or any radiotherapy in the past 4 weeks - Serum creatinine greater than 1.5 x upper limit of institutional normal range - Total serum bilirubin greater than 2 x upper limit of institutional normal range - Current diagnosis of splenomegaly not related to lymphoma - History of prior malignancy, except for lymphoma, curatively treated basal cell carcinoma, squamous cell carcinoma, in-situ cervical carcinoma or a surgically cured malignancy - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Significant non-malignant disease, including documented HIV infection, uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive heart failure (greater than NY Heart Association Class II), poorly controlled diabetes, coronary angioplasty within 6 months, uncontrolled atrial or ventricular cardiac arrhythmias, or active hepatitis C - Haematopoietic growth factors administered within 1 week of study entry. If growth factor support was given during previous chemotherapy cycles, WBC less than 15.0 x 10^9/L was required at enrolment - Treatment with Interferon® during the last 3 months - Known hypersensitivity to E. coli-derived pharmaceutical products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase)
• Subject had previously been randomised into this study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• pegfilgrastim

• filgrastim

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Russell N, Mesters R, Schubert J, Boogaerts M, Johnsen HE, Canizo CD, Baker N, Barker P, Skacel T, Schmitz N. A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate collection of PBPC's to enable transplant following high dose chemotherapy
Secondary	Time to engraftment post-transplant

External Links

•   AmgenTrials clinical trials website